MAUDE Adverse Event Report: BTG Round Lake VISUAL-ICE Cryoablation System; Unit, Cryosurgical, Accessories

Model Number	FPRCH6000
Medical Device Problem Codes	Insufficient Cooling (1130); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that system insufficient ice occurred.This visual-ice cryoablation system was selected for a cryoablation procedure.During the procedure, however, it was noted that there was a negative temperature issue, and that the ice balls were too small, as indicated by the charts.The procedure was completed with this console.There were no patient complications as a result of this event.

• Brand Name: VISUAL-ICE Cryoablation System
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTG Round Lake; 4364 round lake road; arden hills MN 55112
• Manufacturer (Section G): Galil Medical; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 25175722
• Report Number: 2124215-2026-26183
• Device Sequence Number: 16108033
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: (01)00867379000006(11)151215(10)VL0201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: FPRCH6000
• Device Catalogue Number: FPRCH6000
• Device Lot Number: VL0201
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 12/15/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown