MAUDE Adverse Event Report: C2 THERAPEUTICS, INC CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH

Model Number FG 1012/FG 1009

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Dysphagia/ Odynophagia (1815); Stenosis (2263)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

Serious adverse event, likely related to the procedure.The device was not returned for further investigation.Feedback analyzed.

Event Description

(b)(6) 2017.Study patient.Follow-up.The patient was having difficulty swallowing solid food.He has to drink plenty of water to get the food down.The issue was discussed with the physician.The patient had an egd on (b)(6) 201 7 which revealed one moderate, benign intrinsic stenosis at 36 cm.Dilation was performed on (b)(6) 2017.Patient also has la grade a esophagitis with no bleeding at the gej.

Event Description

C2 therapeutics became aware of stricture adverse event on (b)(6) 2017.Initial report referenced in mdr 3008780134-2017-00005.On (b)(6) 2017, a stricture (same stricture location as reported in initial report) was observed at 37 cm during follow-up endoscopy (no cryoballoon procedure performed at this time).Dilation was performed with cre balloon dilator (not part of the cryoballoon system) due to existing scar tissue.

Manufacturer Narrative

This is a supplemental/follow-up report for mdr 3008780134-2017-00005 based on additional information provided by the physician.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).Per request from fda on 26mar2020, supplemental report was submitted with incorrect report number.This report is being submitted to correct the report number from 3008780134-2017-00021 to 3008780134-2017-00005.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH
• Manufacturer (Section D): C2 THERAPEUTICS, INC; 303 convention way ste 1; redwood city CA 94036
• MDR Report Key: 6443314
• MDR Text Key: 71163141
• Report Number: 3008780134-2017-00005
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• PMA/PMN Number: K161202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: FG 1012/FG 1009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention