MAUDE Adverse Event Report: BTG ROUND LAKE ICEFX CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH8000
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was cancelled due a system malfunction.An icefx cryoablation system was chosen for a cryoablation procedure.During preparation prior to the procedure, six iceforce 2.1 cx 90 degree needle were connected to the icefx cryoablation system and encountered ithaw malfunction errors.Each of the six iceforce 2.1 cx 90 degree needles was switched to another channel on the icefx cryoablation system.However, this did not resolve the ithaw malfunction.The procedure was cancelled due to this icefx cryoablation system malfunction.Patient sedation at the time of procedure cancellation is unknown.After the procedure was cancelled, the software of the icefx cryoablation system was updated and the system was restarted, and the system malfunction was resolved.There were no patient complications as a result of this event.

• Brand Name: ICEFX 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 ; 9529306396
• MDR Report Key: 24490489
• Report Number: 2124215-2026-11487
• Device Sequence Number: 10676277
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: (01)00859019006370(11)210323
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K181153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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
• Device Catalogue Number: FPRCH8000
• Device Lot Number: ICP0337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/29/2026
• Date Device Manufactured: 03/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6 X ICEFORCE 2.1 CX 90 DEGREE NEEDLES.
• Patient Sex: Female