MAUDE Adverse Event Report: BTG Round Lake ICEFX CRYOABLATION SYSTEM US; Unit, Cryosurgical, Accessories

Model Number	FPRCH8000-02
Medical Device Problem Codes	Insufficient Heating (1287); Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console was unable to activate ithaw.A icefx cryoablation system us was used for a cryoablation procedure.During the procedure, at the end of the second freeze cycle, the user attempted to initiate active thaw on channel a.There was an ithaw malfunction on the console, and the case was completed by passive thaw.There were no patient consequences as a result of the event.

• Brand Name: ICEFX CRYOABLATION SYSTEM US
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTG Round Lake; 4364 round lake road; arden hills MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 25785671
• Report Number: 2124215-2026-37082
• Device Sequence Number: 13449973
• Product Code: GEH
• UDI-Device Identifier: 00859019006417
• UDI-Public: (01)00859019006417(11)240710(10)105291619
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K181153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FPRCH8000-02
• Device Catalogue Number: FPRCH8000-02
• Device Lot Number: 0105291619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 07/14/2026; 08/26/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/10/2026; 09/23/2026
• Date Device Manufactured: 07/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown