MAUDE Adverse Event Report: C2 THERAPEUTICS CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES

Model Number	FG 1012/ FG 1009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stricture reported by the physician as definitely procedure-related, and possibly device-related.Stricture (narrowing of the esophagus) is a known potential adverse event in endoscopic ablation therapy, and may occur regardless of whether or not there is a device malfunction.Patient symptoms resolved after standard therapeutic intervention (tts balloon dilation).
Event or Problem Description
C2 therapeutics became aware of a stricture event on (b)(4) 2017.The patient was initially treated with the cryoballoon ablation system on (b)(6) 2017.During a follow-up endoscopy examination on (b)(6) 2017, a mild benign appearing, intrinsic stenosis was observed.Patient was dilated and the site was examined and showed complete resolution of the stricture.Final result: resolved without sequelae.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT WITH ACCESSORIES
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way, ste1; redwood city CA 94063
• MDR Report Key: 6970211
• Report Number: 3008780134-2017-00017
• Device Sequence Number: 13720433
• Product Code: GEH
• UDI-Device Identifier: 00854924006125
• UDI-Public: 00854924006125
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/09/2018
• Device Model Number: FG 1012/ FG 1009
• Device Catalogue Number: FG 1012/ FG 1009
• Device Lot Number: 08082017-02 / 02142017-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention