MAUDE Adverse Event Report: C2 THERAPEUTICS, INC. C2 CRYOBALLOON FOCAL ABLATION SYSTEM; CRYOSURGICAL UNIT AND ACCESSORIES

Model Number FG-1012, FG-1009

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

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Pleural Effusion (2010); Stenosis (2263)

Event Date 04/03/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer, and further investigation could not be conducted.There were no performance issues identified for the device during the procedure.The event appears to be unrelated to the device performance.

Event Description

The patient was treated with cryoablation on (b)(6) using the c2 cryoballoon focal ablation system.He had long segment high grade dysplasia, and the doctor performed 26 ablations.The post procedure pain score was 10, and he was already on narcotics for a previous condition.During the holidays, the patient went to his local emergency department complaining of pain and difficulty swallowing but was not scoped.He also had abdominal issues that may have been pre-existing.The patient is on a pureed diet.

Manufacturer Narrative

This is follow-up report for the mdr reference: (b)(4).A commercial patient was originally treated on (b)(6) 2016.The physician planned a follow up cryoballoon procedure on (b)(6) 2017.During the follow up on (b)(6) 2017 there was a stricture noticed; the patient was dilated.The patient was also treated with the cryoballoon the same day in another area.No issue with this procedure was recorded.Stricture requiring treatment is an anticipated adverse event after endoscope ablation therapy.Therefore, this stricture requiring treatment is likely related to the procedure.Patient responded well to treatment of stricture.No report of complications or sequelae.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 3008780143-2017-00006 to 3008780134-2017-0001 follow up #1 note: the following codes on previous follow-up no longer available.3263-actual device not evaluated.3332-quality control review.3372-analysis of data log(s).

Event Description

The follow-up report for the mdr reference: (b)(4).A commercial patient was originally treated on (b)(6) 2016.The physician planned a follow up cryoballoon procedure on (b)(6) 2017.During the follow up on (b)(6) 2017 there was a stricture noticed; the patient was dilated.The patient was also treated with the cryoballoon the same day in another area.No issue with this procedure was recorded.

• Brand Name: C2 CRYOBALLOON FOCAL ABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): C2 THERAPEUTICS, INC.; 303 convention way; suite 1; redwood city CA 94063
• MDR Report Key: 6257455
• MDR Text Key: 64963605
• Report Number: 3008780134-2017-00001
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Catalogue Number: FG-1012, FG-1009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: 04/04/2017
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other