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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76358

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 06, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
C2 Therapeutics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

Z-1477-2017
Recall number
Z-1477-2017
Initiated
January 06, 2017
Classification
Class II
Status
Terminated
Recalling firm
C2 Therapeutics, Inc.
Quantity
755 controller caps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.

Code information

All lots distributed between June 23, 2016 and December 20, 2016: UPDATE - expanded to include product distributed from February 1 2016 through February 8, 2017. All numbers below have been updated. Lot numbers: Expiry dates 01122016-02 12-Jul-16; 06242016-01 1-Jan-2017; 11282016-03 2-Jun-2017; 01042016-03 14-Jul-16; 06292016-02 6-Jan-2017; 09202016-01 21-Mar-2017; 07062016-01 8-Jan-2017; 09222016-01 23-Mar-2017; 01252016-02 02-Aug-16; 07082016-02 13-Jan 2017; 09232016-01 28-Mar-2017; 01282016-01 01-Aug-16; 07082016-03 14-Jan-2017; 09232016-02 27-Mar-2017; 01292016-01 02-Aug-16; 07152016-01 21-Jan-2017; 09292016-01 4-Apr-2017; 02022016-03 09-Aug-16; 07152016-02 20-Jan-2017; 09302016-03 4-Apr-2017; 02082016-01 09-Aug-16; 07212016-01 25-Jan-2017; 10052016-02 19-Apr-2017; 02092016-02 11-Aug-16; 07252016-01 28-Jan-2017; 10142016-01 18-Apr-2017; 02112016-02 17-Aug-16; 07262016-01 9-Feb-2017; 10192016-01 24-Apr-2017; 02172016-02 25-Aug-16; 07282016-02 2-Feb-2017; 10212016-01 25-Apr-2017; 02222016-01 26-Aug-16; 08022016-01 17-Feb-2017; 10242016-01 26-Apr-2017; 03012016-01 04-Sep-16; 08032016-02 5-Feb-2017; 10262016-02 1-May-2017; 03072016-01 10-Sep-16; 08112016-01 16-Feb-2017; 10282016-02 8-May-2017; 03102016-02 15-Sep-16; 08232016-01 26-Feb-2017; 11022016-01 9-May-2017; 03152016-03 21-Sep-16; 08262016-01 2-Mar-2017; 11042016-01 10-May-2017; 03282016-02 29-Sep-16; 09022016-01 8-Mar-2017; 11092016-01 15-May-2017; 03292016-01 31-Sep-16; 09092016-01 14-Mar-2017; 11142016-02 16-May-2017; 09122016-02; 15-Mar-2017; 11152016-02 18-May-2017; 04012016-01 06-Oct-16; 09192016-01 19-Mar-2017; 11162016-01 21-May-2017; 09192016-02 21-Mar-2017; 11282016-02 30-May-2017; 04062016-01 12-Oct-16; 11302016-02 02-Jun-17; 12052016-01 08-Jun-17; 04112016-04 14-Oct-16; 12052016-03 06-Jun-17; 04142016-01 20-Oct-16; 12072016-01 09-Jun-17; 04202016-02 21-Oct-16; 12092016-01 13-Jun-17; 05022016-02 05-Nov-16; 12132016-01 19-Jun-17; 05092016-01 11-Nov-16; 12152016-02 20-Jun-17; 05162016-02 18-Nov-16; 01042017-01 04-Jul-17; 05232016-01 25-Nov-16; 01052017-03 19-Jul-17; 05272016-01 02-Dec-16; 01052017-04 19-Jul-17; 06022016-02 09-Dec-16; 01092017-01 12-Jul-17; 06102016-01 14-Dec-16; 01102017-01 18-Jul-17; 06152016-01 21-Dec-16; 01132017-01 18-Jul-17; 06172016-01 23-Dec-16; 01132017-03 17-Jul-17; 07282016-02 02-Feb-17.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China.

Field note

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